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Treatment of Microscopic Colitis

This study has been terminated.
(insufficient data quality)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184171
First Posted: September 16, 2005
Last Update Posted: January 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Norwegian University of Science and Technology
September 10, 2005
September 16, 2005
January 21, 2015
November 2001
September 2010   (Final data collection date for primary outcome measure)
Symptoms: Stool frequency and consistency [ Time Frame: 2001 - 2011 ]
September 2010: Patient's enrollment completed. Data analysis ongoing.
Symptoms: Stool frequency and consistency
Complete list of historical versions of study NCT00184171 on ClinicalTrials.gov Archive Site
Histological findings in biopsies from colon [ Time Frame: 2001 - 2011 ]
Patient's enrollment completed. Data analysis ongoing.
Histological findins in biopsies from colon
Not Provided
Not Provided
 
Treatment of Microscopic Colitis
Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber
The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis
This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colitis
  • Drug: Budesonide
    Budesonide 9 mg
  • Drug: Bismuth
    Bismuth mixture
  • Drug: Fiber
    Fiber for control
  • Experimental: Budesonide
    Budesonide 9mg
    Intervention: Drug: Budesonide
  • Experimental: bismuth
    Bismuth mixture
    Intervention: Drug: Bismuth
  • Sham Comparator: Fiber
    Fiber preparation
    Intervention: Drug: Fiber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
105
October 2014
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Microscopic colitis verified with biopsies from the colon
  • Symptoms to such an extent that treatment is indicated
  • Age > 17 years
  • Informed consent

Exclusion Criteria:

  • Previous treatment with any of the investigational drugs
  • Patients treated with ketoconazole
  • Pregnant and breast-feeding females
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00184171
SLV 01-07035
No
Not Provided
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
AstraZeneca
Study Chair: Per G Farup, PhD Norwegian University of Science and Technology
Norwegian University of Science and Technology
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP